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The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients

The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document describes a 510(k) summary for a medical device called "NeoPIP™ Resuscitation Circuit with PEEP," which is a physical breathing circuit for neonatal resuscitation.

The submission focuses on establishing substantial equivalence to a predicate device based on design, materials, and operational and technological characteristics, not on the performance of a software algorithm or AI model. Therefore, directly answering the questions related to AI/ML performance metrics, sample sizes for test/training sets, experts, and ground truth as outlined in the prompt is not possible from the provided text.

Here's a breakdown of why each requested point cannot be addressed:

1. Table of acceptance criteria and reported device performance: Not applicable. The document discusses "performance data" in the sense of demonstrating equivalence to a predicate device, not in the context of specific quantitative performance metrics for an AI/ML system.
2. Sample size for test set and data provenance: No test set is mentioned, as this is a hardware device.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for AI/ML is not relevant for this device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as it's not an AI-assisted diagnostic tool.
6. Standalone (algorithm only) performance: Not applicable, as there is no algorithm described.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

Instead, the document focuses on:

• Intended Use: An accessory to add positive end expiratory pressure (PEEP) breathing capability to a T-Piece Resuscitator for neonatal patients

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